EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190 (UDI 04953170305276)Recalls & reported problems
Olympus Medical Systems Corp. · GIF-HQ190 EVIS EXERA III HDTV DF NBI · Class 2
All models of EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA III colonoscope is a flexible scope. Of its 6,682 reports, 5 describe deaths and 78 describe injuries; many describe scopes that did not clean adequately, had communication problems or poor images. Reports rose from 764 in the prior year to 4,338 in the latest year. There are 3 open recalls: a connector repair that can cause image loss, a drying step that left some scopes wet inside, and a mismatched part.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 6,244
- Deaths reported
- 5
- Injuries reported
- 78
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 6,244 adverse event reports that list this exact device (DI 04953170305276), received between May 14, 2018 and Sep 30, 2026 — classified as 5 deaths, 78 injuries, 6,161 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (2,307 reports).
3 FDA recall records name this device's identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 16, 2023Class IIOpen, Classified
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Z-0417-2024 · Root cause: Process control · Recall details · FDA record ↗
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0334-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 22, 2022Class IIOpen, Classified
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
Z-1275-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately2,307
- Communication or Transmission Problem726
- Poor Quality Image698
- Device Reprocessing Problem610
- No Display/Image594
- Residue After Decontamination511
- Microbial Contamination of Device471
- Erratic or Intermittent Display156
Patient problems
- No Clinical Signs, Symptoms or Conditions6,011
- No Known Impact Or Consequence To Patient69
- No Consequences Or Impact To Patient56
- Insufficient Information31
- Bacterial Infection29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available13
- Perforation9
- Hemorrhage/Blood Loss/Bleeding8
Recent adverse event reports
The 25 most recent of 6,244 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954660 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952467 ↗MalfunctionSep 30, 2026Residue After Decontamination
The customer reported that the Gastrointestinal Videoscope exhibited something within the air/water channel, with some kind of debris observed at the distal tip during inspection for use. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950901 ↗MalfunctionSep 30, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal videoscope to the service center for a separate issue. During initial investigation of the device foreign objects were found within the auxiliary jet channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948503 ↗MalfunctionSep 30, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal videoscope to the service center for a separate issue. During initial investigation of the device white foreign material were found in the air/water cylinder and air/water tube and air /water cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947939 ↗MalfunctionSep 30, 2026Device Reprocessing Problem
The customer returned the device which is an Olympus asset Gastrointestinal Videoscope with no reported complaint. During initial investigation of the device foreign objects were found in the air/water cylinder and air/water tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947645 ↗MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem
It was reported that the Gastrointestinal Videoscope would not communicate with the video processor. The issue occurred during reprocessing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947136 ↗MalfunctionSep 30, 2026Residue After Decontamination
The customer returned the Gastrointestinal Videoscope, which is an Olympus asset with no reported complaint. During the initial evaluation of the device, it was observed that the air/water channel and the air/water cylinder had white foreign material. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947083 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display
The customer returned the Gastrointestinal Videoscope for a separate issue. During inspection of the device, it was found that the image was distorted. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937951 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
It was reported that the Gastrointestinal Videoscope had something in the air/water channel and there was debris at the distal tip. The issue was found during device setup. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937366 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During device analysis, the service technician identified that the device had white foreign material in the auxiliary water channel and the air/water channel and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936388 ↗MalfunctionSep 29, 2026Misfocusing
The customer reported the gastrointestinal videoscope for a blurry image during inspection for use. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935166 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
The customer reported an E217 error during inspection for use involving an Olympus Gastrointestinal Videoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935017 ↗MalfunctionSep 29, 2026Break; Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934744 ↗MalfunctionSep 29, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934062 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927006 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927005 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927004 ↗MalfunctionSep 28, 2026Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926618 ↗MalfunctionSep 28, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925890 ↗MalfunctionSep 28, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924078 ↗MalfunctionSep 28, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924027 ↗MalfunctionSep 28, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924021 ↗MalfunctionSep 28, 2026No Display/Image; Communication or Transmission Problem
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the initial evaluation of the returned device, a scope communication error E216 and no image were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923724 ↗MalfunctionSep 28, 2026Poor Quality Image
It was reported, that the Videoscope had a fuzzy image. There were no reports of patient harm as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923547 ↗
Other Colonoscope and accessories, flexible/rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls1,315 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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